This flawed, unethical study will help fuel the multi-billion dollar homeopathic industry.

September 19, 2015

The absolute absurdity of this “published” research study is beyond mind boggling. The tragedy is that it will likely fulfill its purpose of serving as the reference cited for the phrase “clinically proven” that will appear on some future product from the French homeopathic manufacturer, Boiron. A greater tragedy is that Boiron continues to thrive not because their products are actually effective, but because people will continue to buy them because they “believe” they work. Basing health decisions on beliefs, feelings, superstitions, or hearsay plays directly into the hands of peddlers of homeopathic therapies. In the United States alone, Americans spend $39 billion on these useless products.[1]

There is no scientific basis for the efficacy of homeopathic magical potions. There simply isn’t. And yet, manufacturers of homeopathic products attempt to provide empirical evidence by buying “researchers” to perform “studies” that will be “published” and cited as evidence of the potion’s efficacy. The only thing effective in this process is that Boiron makes a ton of money. In fact, in 2014, their top-line sales were $690,000,000, all of which was from selling homeopathic potions. It’s bizarre.

All of this is prelude to an inspection of the recently published study impressively titled, Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population. Here are the principle problems.

Half of the participants received just a homeopathic potion to treat an upper respiratory tract infection (URTI). The other half received the same potion, and in addition, despite there being no clinical basis for it, they also received an antibiotic. The authors clearly state in the paper that antibiotics are inappropriate for treating a URTI. This raises serious ethical questions of providing a medication when it is known that it is not indicated.

Since both groups received the same homeopathic potion there was no control group. However, that did not deter the authors from concluding that the potion was effective for. Think about that one for a minute. Both groups given the same medication and the authors conclude it works –compared to what?

The study was paid for by a grant from Boiron.

The study was published in an obscure journal that charges $2,000 to publish a paper.

It’s based on homeopathic principles where efficacy is proportional to dilution. That’s right – the less you have of something, the more effective it becomes. In this study, ingredients are diluted one trillion times.

In essence, Boiron paid researchers to concoct a study that would show their placebo worked, and in turn paid an obscure journal to publish the results. The study itself was hopelessly flawed using two placebos to show the placebo worked. The study also has serious ethical shortcomings in that one group received a medication that was clearly not indicated. It will not be surprising when this study shows up in the marketing literature of Boiron as “clinical proof” for their products. That’s the story in a nutshell, but diving a little deeper into the details reveals just how bizarre this story is.

Well, it sure looks like a real study.

At the time of this post, the study is available at this link, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4527103/ and is also attached as a PDF. The first thing to note is how having a paper on the National Institutes of Health (NIH) official website might confuse a reader who is unfamiliar with evaluating scientific literature. Seeing a paper on an NIH site might be construed as an endorsement of the work. The screenshot below may imply a credibility that doesn’t exist.

What, exactly, is in the potion the study participants received?

The homeopathic potion used in the study is a combination of the following plants and mineral, and water –lots and lots of water.

Anemone pulsatill

Rumex crispu

Bryonia dioica

Ipecacuanha

Spongia tosta

?????

Sticta pulmonaria

Antimonium tartaricum

Myocarde

Coccus cacti

Drosera

Homeopathy is based in the belief that the more something is diluted, the more effective it becomes. It’s the epitome of the adage, “less is more.” In this paper, a common dilution is 6C where C represents a one hundred fold dilution making 6C a trillion fold dilution. To put this in perspective, a rectangle of water the size of a football field and 30 tall would contain around 11 million gallons. Now, envision adding one drop of gin and one drop of vermouth to the water and shake, don’t stir, until completely blended to create a 6C dilution or the world’s weakest martini. Welcome to the world of homeopathy.

Antibiotics for a viral infection

It is dumbfounding that this study ever passed an Institutional Review Board. Knowingly giving a medication that is known not to be effective is unambiguously unethical. In the following statement the authors acknowledged that antibiotics were inappropriate but they were going to give them anyway.

“A Cochrane review of antibiotic use for cough and common cold concluded that there was not enough evidence of important benefits in the treatment of URTI, whereas there was a significant increase in adverse effects associated with antibiotic use .However, parents are rarely satisfied with in the watchful approach, and often have an expectation that antibiotics should be prescribed.”

“Eighty-five children were found eligible to be enrolled in the study. Forty-six patients received homeopathic syrup alone for 10 days (Group 1) and thirty-nine children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days (Group 2).”

But did it work?

By 10 days, all URTIs were resolved in both groups, which, not coincidentally, is the expected time to resolution with no intervention. However, there were differences between the groups in signs and symptoms related to antibiotic administration. For example, 23.4% of children in the homeopathic potion plus antibiotic group developed diarrhea while none of the homeopathic potion only group developed diarrhea. Again, the ethics question surfaces, but ethics and study design did not dissuade the authors from concluding the following.

“In conclusion, our data confirm that the studied homeopathic treatment has potential benefits on cough in children, as well as highlighting the good safety profile of this treatment. Supplementing the syrup with antibiotics did not improve cough resolution and was associated with more adverse events than the homeopathic syrup alone. These results indicate that antibiotics should not be routinely prescribed for uncomplicated acute cough secondary to URTI, as they are inappropriate for this condition and might be even dangerous– leading to increased antimicrobial resistances and adverse events, without evidence of benefit.”

Absurd. It’s simply absurd to conclude that a treatment was effective when there was no control. Regardless of the absurdity the paper was published and will end up in Boiron’s marketing slicks.

Want to publish a paper? Got $1,940? You’re good!

Another indication of the worthlessness of this paper is where it was published – the Multidisciplinary Respiratory Medicine. This “journal” appears to be a paper mill where virtually any article will be published with only cursory, if any,review as long as the submission is accompanied by $1,940 – credit cards accepted. (http://www.mrmjournal.com/about/apcfaq/howmuch)

The obscurity of Multidisciplinary Respiratory Medicine is impressive. Scientific journals are scored based on the quality of their publications and the number of times articles are cited. The greater the number of citations, the greater is the journal’s Impact rating. The higher the rating, the more credible is the journal. For example, the prestigious New England Journal of Medicine has a score of 54.42 and Nature has a score of 42. At the other end of the spectrum are journal such as Bulletin of the Iranian Mathematical Society with a score of 0.27 or the Balkan Journal of Medical Genetics with a score of 0.17. How did the Multidisciplinary Respiratory Medicine do? 0.15. [2],[3]

Does it matter that the journal has no credibility? To scientists yes, but to the study authors and Boiron, not so much. It is clear that the purpose of the publication was not to advance our knowledge or report anything remotely meaningful. No, the purpose was to get a reference for Boiron’s marketing department. Sadly, based on Boiron’s finances this strategy has apparently worked.

Homeopathy is big business

It is a testament to the gullibility of the human mind that Boiron’s financial sheet is so impressive. The screenshot below is from EuroNext[4] and shows 2014 net sales of 609,748,000 Euros or approximately 690 million US dollars. Who knew you could sell $690 million worth of water?

People will be people

I hate to end on this thought but despite the glaring evidence that homeopathy does not and cannot work, a certain segment of the population will not relinquish their belief that it works – for them. Their emotional loyalty to natural “cures”, their suspicion of real medicine and its complexities, and their thirst to feel empowered and in control of their own destiny will fill the coffers of companies like Boiron for the foreseeable future. It’s a pity, really. Humans should better than this, humans can be better than this, but we’re not. As long as people are willing to make uninformed choices, there will be industries to happily exploit their ignorance.